Dublin, May 14, 2025 (GLOBE NEWSWIRE) -- The "Risk-based Computer System Validation; Reduce Costs and Avoid 483s (ONLINE EVENT: August 6-7, 2025)" has been added to ResearchAndMarkets.com's offering.
Dublin, March 10, 2025 (GLOBE NEWSWIRE) -- The "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" training has been added to ResearchAndMarkets.com's offering. Upon ...
DUBLIN--(BUSINESS WIRE)--The "CSV Boot Camp - 3-Day Certification Course" training has been added to ResearchAndMarkets.com's offering. This seminar is intended for those involved in planning, ...
(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities lie in integrating modern technology and agile methodologies to enhance compliance with FDA regulations. Emphasis on cloud services, validation ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...
Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Vivek Yadav, an engineering manager from ...
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic ...
Regulation and the pharmaceutical sector are intrinsically linked. Indeed, it’s no exaggeration to state that the global pharmaceutical sector is one of the most heavily regulated industries in the ...
You know you need a validation master plan, but what should it include and what separates a strong validation master plan from an ineffective one? Marie Thibault We asked Ken Link, director of quality ...
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